MAUDE Adverse Event Report: ABBOTT VASCULAR GRAFTMASTER; CORONARY STENT DELIVERY SYSTEM

Catalog Number 1012583-16

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents.The investigation determined that the reported device damaged by another device appears to be related to circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The wiggle guide wire referenced was filed under a separate medwatch report number.

Event Description

Initial information received via user facility medwatch regarding a wiggle guide wire states: when attempted to remove wire, the tip broke off and became entrapped behind covered stent.Patient remained hemodynamically stable throughout event and recovery.Additional information received indicates that the procedure was to treat a free perforation in the mid right coronary artery (rca).The wiggle guide wire was trapped when a graftmaster covered stent was implanted.The perforation was sealed.When attempting to remove the wire there was significant resistance and the tip detached.The tip was embedded to the vessel wall by the use of an additional stent.The patient was discharged the following day.No additional information was provided.

• Brand Name: GRAFTMASTER
• Type of Device: CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 9194893
• MDR Text Key: 173562417
• Report Number: 2024168-2019-12643
• Device Sequence Number: 1
• Product Code: MAF
• UDI-Device Identifier: 08717648176470
• UDI-Public: 08717648176470
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H000001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 1012583-16
• Device Lot Number: 8073141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 77